Imagine the possibilities of GLOBAL RECORDKEEPING for the cost of Lunch!

This is an example of a farm record that will follow the commodity throughout the supply chain. Complete and secure.

https://www.scoringag.com/scoringag/3/Ag.cfm?sfa=main.PSA&entity_id=SSI_A7237BA48A

 

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Top 10 Reasons Act Now FSMA Compliance

With FDA already over the original due date for FSMA rules, extending comment periods, and being subjected to lawsuits and court mandates because of that, the government shutdown certainly has not helped to move things along. However, this does not mean that the food industry should sit back and wait for the rules to be finalized or compliance to take effect. There are numerous reasons you should be working toward compliance now – many of which are, like the rules themselves, interdependent.

Following are 10 Reasons you should be working toward FSMA compliance now:

1. Prevention vs. Reaction –

Moving the industry from reaction to prevention is the foundation of FSMA. Acting now is preventive; waiting until all the rules are in place and the deadline is pending is reactive. Further, much of what is in FSMA is good for brand protection, so paying attention to these rules today will help you develop systems that have other important impacts on your business. (See #9.)

2. The Devil is in the Details –

If you’ve taken a look at the proposed rules, you know that they are quite detailed. The longer you wait to review the rules and apply them to your business, the more you can expect to be scrambling to try to meet the compliance dates – particularly if you find that you are subject to more than one rule with interdependent clauses. (See #3.) When you rush to complete a task, you are more likely to make mistakes or miss those devilish details. Think about any project you recently undertook. Did you give yourself enough time to thoroughly review the specifications, strategize and plan, take action to implement the plan, then evaluate it to ensure that it not only fits the specifications but also is effective for your business? If you waited until the last minute to start the project, you probably did not have enough time to implement each of the steps needed for success. In the same way, if you wait until the last minute to begin working on the FSMA rules, it’s unlikely you will give yourself enough to do much more than simply take action and hope for the best.

3. Multiple Rule Compliance –

The complexity and interdependence of the FSMA provisions are a primary reason that FDA has had to take extra time to develop the rules and has extended the comment periods. In much the same way, every business will have to interpret the complex details of at least one rule; and most businesses will be subject to multiple rules and have to take into consideration the interdependence of each. For example, the Preventive Controls rule will impact most businesses in one way or another; if you grow, harvest, pack, or hold produce, you will also be subject to the Produce Safety rule; and if you use any imported ingredients or supplies, you may be impacted by the Foreign Supplier Verification Program (FSVP) and the Accredited Third-Party rule – all of which are interdependent.

4. Training –

Implementing practices and standards in your operation to ensure compliance with the rules will require personnel training. If you are still in the process of developing compliant standards when the deadline looms, you will have no opportunity to educate or train your workers in your new standards.

5. ROI –

Start monitoring critical operations and save time and money by seeing that things need a correction before you have a problem on your hands. Identify corrective actions before there is an issue so that you don’t need to reinvent the wheel or waste time trying to remember what you did last time. Similarly, have a recall plan so that there isn’t mass confusion on who does what when (not if) you have a recall.

6. Improve Food Safety –

Besides the direct standard-making practices of the first four reasons there is also a business case to be made for implementing improved practices that meet or exceed FSMA rules. If the proposed rules contain preventive controls or safety measures that you are not already implementing in your facility, you are likely at risk for a food safety violation and/or recall – and all the negative media attention and economic reprisals that entails. (See #7 and #8.) If you have any doubts along these lines, read our blog from last week: Are We in a New Era of Federal Prosecutions for Food Safety?

7. Brand Protection –

While business closure and complete loss of brand is an extreme result, any food safety violation (unintended or not) or recall can, and usually does, garner undesirable media attention. And today, media is not only the local paper or national TV news, it is also the homemaker blogger, the teenage tweeter, and the cause-centric consumer activist, all of whom have open access to Internet posting of information – and misinformation. The more you protect the safety of your food through regulated or unregulated preventive-based controls, the more you protect your brand.

8. Move Toward or Maintain Certification to a GFSI-benchmarked Scheme –

There are many parallels between the FSMA Preventive Controls rule and GFSI standard. Take SQF for example – Although there are elements of SQF and other GFSI-benchmarked schemes that are not as prescriptive as FSMA, there are several areas addressed by SQF that have not been addressed in the proposed rule. Thus, as the food industry looks to protect customers and their brand as well as be in compliance with the proposed new rules, our own analysis indicates that being SQF level 2 certified to today’s SQF standards is a very strong start. If you’re already certified, keep improving (#9); if you’re not, consider if implementing preventive controls warrants the pursuit of certification to a GFSI scheme.

9. Best Practices for Continuous Improvement –

Implementing best practices should be a basic practice for every food facility, and there are plenty of best practices written into the proposed rules that will enable a facility to improve. Implementing best practices gleaned from this review of the rules will not only move you toward compliance, it will help you continuously improve.

10. Just Do It –

Although the final rules are unlikely to be exactly the same as the proposed rules, getting started will certainly give you a leg up. And if you work toward complying with the strictest of the proposed rule, you will be closer to being ready if the final rule is even stricter. And if the final rule is less strict? Worst case, you will be over safe; certainly not a bad thing! The bar of FSMA is not that high – do you really want to be only as good as the lowest common denominator?

By David Acheson
The Acheson Group

 

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USA Jean Traceability

USA Jean Traceability http://www.youtube.com/watch?v=1kjWgd8xWCM #paperli

PCCA, All American Clothing Company and American Cotton Growers share their story.

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What do Cantaloupe and Baseball have in Common

I stopped being a fan of Alex Rodriquez years ago when he left the Mariners, so I was not that particularly bothered when he was banned from baseball for steroid use.

A-Rod’s banning, along with the past steroid-induced sins of Mark McGwire, Barry Bonds and others, show that player punishment or embarrassment does not always stop the crime.

No serious person can believe that players have an incentive to play “clean.” More homers and strikeouts mean more fans in the stands, or glued to TV commercials, and even more revenue for the owners. More revenue for owners translates into bonuses for players, incentivizing players to cheat. Owners talk all season about the evils of steroid use as they stuff great gobs of money into their pockets that they make from players advantaged by steroids.

Money talks and ethics walk.

Players are the well-paid chattel of owners who want to win at any cost. Owners may well feign ignorance of steroid-induced homers or strikes, but they covet them nonetheless. Banning A-Rod changes nothing.

Want to change the direction of baseball overnight? Change the incentives. If the Yankees had been banned from Baseball for a year and a half — not A-Rod — you can bet that no player in baseball would touch the stuff again.

So, what does cantaloupe have to do with Baseball? Much, in addition to both being round. Like players and the baseball industry, incentives are wrong with cantaloupe growers — actually all food — and the retail industry.

In 2011, Listeria-tainted cantaloupes grown in Eastern Colorado sickened 147 in two dozen states, killing at least 33. It was the largest foodborne outbreak death toll in the United States in 100 years. That is saying a lot given that the Centers for Disease Control and prevention estimate that food sickens 48,000,000, hospitalizes 135,000 and kills over 3,000 each year.

The year before, a third generation cantaloupe grower had been enticed by a broker-shipper preferred by Walmart and Kroger to expand its market nationwide. An auditor recommended by Walmart inspected the farm and packing shed in 2011, while the cantaloupes were actually being washed by un-chlorinated, Listeria-tainted water. The farm, as with most food audits, got a superior rating of 96%. That was the green light for the cantaloupes to ship to your local Walmart or Kroger.

Those same retailersdistance themselves from such behavior, clucking constantly about food safety from “farm to fork” and creating a “culture of food safety.” They hire auditors as middlemen in the food-safety chain to give them cover to ignore food safety risks.

The grower of the tainted cantaloupe has gone bankrupt. The grower is also facing criminal misdemeanor charges for selling food considered to be “adulterated,” which according to Federal law is food that “bears or contains any poisonous or deleterious substance, which may render it injurious to health.” These charges, unlike a felony charge, “do not require proof of fraudulent intent, or even of knowing or willful conduct.” The grower does face fines and jail nonetheless.

Countless other growers and manufacturers of food produced in the last decades have faced both civil and criminal liability — yet food poisoning continues.

Sound a bit like players facing suspension over and over again?

Retailers, like team owners, require audits, set the rules, called specifications, for how food — like cantaloupes — should be safely produced. They then ignore their own rules because living by their rules costs a cent or two more, and that seems not worth the price. Why? Because just like Baseball owners who can pass the buck to the players, it is not retailers who are on the hook if there is a problem — the growers are.

Team owners squeeze their players by demanding performance. No home runs or strike-outs — no place on the team. Retailers squeeze their suppliers on price. Not the lowest price? You are out. In fact, retailers squeeze growers for the last bit of profit, leaving little for growers to invest in producing safer food – an oddly perverse incentive.

Want to change the direction of food safety overnight? Change the incentives.

Most Americans do not realize that the retailers they buy their food from are mainly insulated from civil and criminal liability. Only their suppliers have liability. But, if we were to put the onus of compensating customers for medical bills and lost wages onto the retailers that profit the most from the sale, their incentives to buy food that will not kill you would go up a lot.

Want to change the incentive of a retailer who sells you food that can make you sick or kill you? Have them face jail time or fines if they do.

Want to make food safer from “farm to fork” in a “culture of food safety?” Pay fair wages to farm workers and fair prices to growers. Both are investments in safer food.

Like steroid use in baseball, food safety will not change until those with the most power have the incentive to change behavior. Banning players or bankrupting cantaloupe growers does nothing to change the dynamic. Banning baseball owners would stop steroid use overnight. Fining or jailing retailers who sell food that kills people – well, that will do it.

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Food fraud alert!

1.23.2013, 13:48 PM
Food fraud alert! Pomegranate juice, olive oil, seafood and spices are among the foods that aren’t always what they seem: report

C.O.T/a.collectionRF/Getty Images/amana images RF
Think you’re eating white tuna? Think again, a new report says — some food manufacturers may be swapping in escolar, a less expensive fish that’s been linked to a type of food poisoning.

Attention, shoppers: Sometimes what you think you see on the grocery store shelf isn’t really what you’re getting.

The nonprofit U.S. Pharmacopeial Convention released a new update to its Food Fraud Database on Wednesday, documenting instances of food fraud as reported by the media and scientific journals.

Food fraud is defined as “deliberate substitution, addition, tampering or misrepresentation of food, food ingredients or food packaging, or false or misleading statements made about a product for economic gain,” according to the organization.

Among the most offending foods are common products like olive oil, fruit juices, spices and seafood. In many cases, more expensive foods are filled out or replaced with less expensive, and sometimes potentially harmful, substitutes.

IS IT ETHICAL TO EAT QUINOA?

Foods become “fraudulent” when the manufacturer isn’t up front with the U.S. Department of Agriculture, the Food and Drug Administration or other regulatory agencies about what’s going into its products, Dr. Markus Lipp, senior director of food standards at USP told the Daily News.

“In general, the U.S. food supply is very safe, because of the vigilance of the FDA, the food industry and consumers,” he said. “With the database, we try to promote informed decision making.”

The USP added 800 new records to its database, reflecting the years 2011-2012. Here are some of the most fraudulent foods it found:

Robert Medvedenko/Getty Images/StockFood

Be wary of products labelled “100% pomegranate juice,” the report says.

Pomegranate juice: Some products labelled “100% pomegranate juice” may be filled out with other fruit juices or with sugar water.

Olive oil: Some olive oils are diluted with less-expensive vegetable oils, the report says.

Spices: Powdered spices like saffron, turmeric and chili powder may be diluted or replaced with less-expensive spices or fillers.

White tuna: The “white tuna” on your sushi menu may actually be less-expensive escolar, a fish that is banned in other countries including Italy and Japan. It has a high content of waxy esters that contribute to a type of food poisoning called gempylotoxism. Escolar is legal in the U.S., but the Food and Drug Administration advises against selling or consuming it.

‘PINK SLIME’ TAINTED WITH E. COLI KILLED MINNESOTA MAN, SUIT CLAIMS

Lemon juice, other fruit juices and jams: Foreign manufacturers sometimes sneak clouding agents into these to make them look fresh-squeezed. Roughly 4,000 people in Taiwan became sick from ingesting products laced with dangerous pthalates, a chemical also found in plastic, according to the report.

Honey and maple syrup: High fructose corn syrup or other sugars might be snuck in to enhance sweetness.

Coffee: Fillers can be added to ground coffees to increase their volume.

There are several steps consumers can take to avoid food fraud, Lipp said. They include:

Do your homework. Don’t be afraid to contact manufacturers to ask about their ingredients and how their products are sourced.
Buy whole foods when possible. We know how a whole coffee bean or a black peppercorn should look, but it’s much more difficult to spot inconsistencies in a pre-ground powder.
If it seems like too good a deal, it probably is. If you spot a gallon of “extra-virgin” olive oil that’s much cheaper than similar products, you might not be getting what you bargain for.
For the full report and to search the Food Fraud Database, visit foodfraud.org.

1.23.2013, 13:48 PM
Food fraud alert! Pomegranate juice, olive oil, seafood and spices are among the foods that aren’t always what they seem: report

C.O.T/a.collectionRF/Getty Images/amana images RF
Think you’re eating white tuna? Think again, a new report says — some food manufacturers may be swapping in escolar, a less expensive fish that’s been linked to a type of food poisoning.

Attention, shoppers: Sometimes what you think you see on the grocery store shelf isn’t really what you’re getting.

The nonprofit U.S. Pharmacopeial Convention released a new update to its Food Fraud Database on Wednesday, documenting instances of food fraud as reported by the media and scientific journals.

Food fraud is defined as “deliberate substitution, addition, tampering or misrepresentation of food, food ingredients or food packaging, or false or misleading statements made about a product for economic gain,” according to the organization.

Among the most offending foods are common products like olive oil, fruit juices, spices and seafood. In many cases, more expensive foods are filled out or replaced with less expensive, and sometimes potentially harmful, substitutes.

IS IT ETHICAL TO EAT QUINOA?

Foods become “fraudulent” when the manufacturer isn’t up front with the U.S. Department of Agriculture, the Food and Drug Administration or other regulatory agencies about what’s going into its products, Dr. Markus Lipp, senior director of food standards at USP told the Daily News.

“In general, the U.S. food supply is very safe, because of the vigilance of the FDA, the food industry and consumers,” he said. “With the database, we try to promote informed decision making.”

The USP added 800 new records to its database, reflecting the years 2011-2012. Here are some of the most fraudulent foods it found:

Robert Medvedenko/Getty Images/StockFood

Be wary of products labelled “100% pomegranate juice,” the report says.

Pomegranate juice: Some products labelled “100% pomegranate juice” may be filled out with other fruit juices or with sugar water.

Olive oil: Some olive oils are diluted with less-expensive vegetable oils, the report says.

Spices: Powdered spices like saffron, turmeric and chili powder may be diluted or replaced with less-expensive spices or fillers.

White tuna: The “white tuna” on your sushi menu may actually be less-expensive escolar, a fish that is banned in other countries including Italy and Japan. It has a high content of waxy esters that contribute to a type of food poisoning called gempylotoxism. Escolar is legal in the U.S., but the Food and Drug Administration advises against selling or consuming it.

‘PINK SLIME’ TAINTED WITH E. COLI KILLED MINNESOTA MAN, SUIT CLAIMS

Lemon juice, other fruit juices and jams: Foreign manufacturers sometimes sneak clouding agents into these to make them look fresh-squeezed. Roughly 4,000 people in Taiwan became sick from ingesting products laced with dangerous pthalates, a chemical also found in plastic, according to the report.

Honey and maple syrup: High fructose corn syrup or other sugars might be snuck in to enhance sweetness.

Coffee: Fillers can be added to ground coffees to increase their volume.

There are several steps consumers can take to avoid food fraud, Lipp said. They include:

Do your homework. Don’t be afraid to contact manufacturers to ask about their ingredients and how their products are sourced.
Buy whole foods when possible. We know how a whole coffee bean or a black peppercorn should look, but it’s much more difficult to spot inconsistencies in a pre-ground powder.
If it seems like too good a deal, it probably is. If you spot a gallon of “extra-virgin” olive oil that’s much cheaper than similar products, you might not be getting what you bargain for.
For the full report and to search the Food Fraud Database, visit foodfraud.org.

Joff Lee/Getty Images

Ground versions of costly spices like saffron and tumeric might be packed with fillers in order to b1.23.2013, 13:48 PM
Food fraud alert! Pomegranate juice, olive oil, seafood and spices are among the foods that aren’t always what they seem: report

C.O.T/a.collectionRF/Getty Images/amana images RF
Think you’re eating white tuna? Think again, a new report says — some food manufacturers may be swapping in escolar, a less expensive fish that’s been linked to a type of food poisoning.

Attention, shoppers: Sometimes what you think you see on the grocery store shelf isn’t really what you’re getting.

The nonprofit U.S. Pharmacopeial Convention released a new update to its Food Fraud Database on Wednesday, documenting instances of food fraud as reported by the media and scientific journals.

Food fraud is defined as “deliberate substitution, addition, tampering or misrepresentation of food, food ingredients or food packaging, or false or misleading statements made about a product for economic gain,” according to the organization.

Among the most offending foods are common products like olive oil, fruit juices, spices and seafood. In many cases, more expensive foods are filled out or replaced with less expensive, and sometimes potentially harmful, substitutes.

IS IT ETHICAL TO EAT QUINOA?

Foods become “fraudulent” when the manufacturer isn’t up front with the U.S. Department of Agriculture, the Food and Drug Administration or other regulatory agencies about what’s going into its products, Dr. Markus Lipp, senior director of food standards at USP told the Daily News.

“In general, the U.S. food supply is very safe, because of the vigilance of the FDA, the food industry and consumers,” he said. “With the database, we try to promote informed decision making.”

The USP added 800 new records to its database, reflecting the years 2011-2012. Here are some of the most fraudulent foods it found:

Robert Medvedenko/Getty Images/StockFood

Be wary of products labelled “100% pomegranate juice,” the report says.

Pomegranate juice: Some products labelled “100% pomegranate juice” may be filled out with other fruit juices or with sugar water.

Olive oil: Some olive oils are diluted with less-expensive vegetable oils, the report says.

Spices: Powdered spices like saffron, turmeric and chili powder may be diluted or replaced with less-expensive spices or fillers.

White tuna: The “white tuna” on your sushi menu may actually be less-expensive escolar, a fish that is banned in other countries including Italy and Japan. It has a high content of waxy esters that contribute to a type of food poisoning called gempylotoxism. Escolar is legal in the U.S., but the Food and Drug Administration advises against selling or consuming it.

‘PINK SLIME’ TAINTED WITH E. COLI KILLED MINNESOTA MAN, SUIT CLAIMS

Lemon juice, other fruit juices and jams: Foreign manufacturers sometimes sneak clouding agents into these to make them look fresh-squeezed. Roughly 4,000 people in Taiwan became sick from ingesting products laced with dangerous pthalates, a chemical also found in plastic, according to the report.

Honey and maple syrup: High fructose corn syrup or other sugars might be snuck in to enhance sweetness.

Coffee: Fillers can be added to ground coffees to increase their volume.

There are several steps consumers can take to avoid food fraud, Lipp said. They include:

Do your homework. Don’t be afraid to contact manufacturers to ask about their ingredients and how their products are sourced.
Buy whole foods when possible. We know how a whole coffee bean or a black peppercorn should look, but it’s much more difficult to spot inconsistencies in a pre-ground powder.
If it seems like too good a deal, it probably is. If you spot a gallon of “extra-virgin” olive oil that’s much cheaper than similar products, you might not be getting what you bargain for.
For the full report and to search the Food Fraud Database, visit foodfraud.org.

Joff Lee/Getty Images

Ground versions of costly spices like saffron and tumeric might be packed with fillers in order to bring down the price, duping consumers in the process.

Author:
TRACY MILLER

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Why Retailer CEOs are the Biggest Part of Food Safety

Food Safety and the CEO – Keys to Bottom Line Success

Foodborne illness has, of course, been around as long as there has been food. But the identification and diagnosis of these diseases is an emerging science that is changing all sectors of the food business, and those chief executive officers (CEOs) and senior level directors and managers who do not keep up are bound to be at a significant disadvantage when making critical decisions about their businesses.

It is one thing to read or view media reports on the latest foodborne illness outbreaks and brand-damaging product recalls; it is quite another to really understand the widespread, adverse impact these incidents have on your consumer base, on your employees, on the efficiencies of your operations, and ultimately, on your bottom line. In other words, today’s food company CEO needs to know a lot more than producers in the fresh-cut produce industry initiated massive recalls last week, or that a regional restaurant chain closed down, or that a spate of pet fatalities due to the inclusion of a banned substance on an international scale means his or her company should look more closely at imported ingredients for awhile.

What you, the CEO, should know about food safety comes down to a few key concepts. First, all companies along the food supply chain need to go beyond managing the business: To be successful, food companies are now in the business of managing risk. This means garnering a good understanding of why food safety is important to your business, what risks there are to the business, how you can mitigate or eliminate those risks, and how in doing so the food safety program will provide a return on your investment.

Why Food Safety Needs Your Immediate Attention

E. coli O157:H7, which occupies much of my professional time as an attorney, was only first recognized as a human pathogen in 1982 during an outbreak of illness caused by hamburgers from a fast food restaurant in Oregon.(1) But, the problem drew little public attention for another decade when, finally, 600 people across the West, most of them children or senior citizens, became ill after eating undercooked Jack in the Box hamburgers.(2) Four children died, and many others suffered terrible kidney damage, which may eventually lead to the need for transplants.

I became involved when a friend of woman for whom I’d done some pro bono work years earlier contacted me. The friend’s daughter, Brianne Kiner, had eaten one of those burgers, and was in the hospital with hemolytic uremic syndrome (HUS). Brianne proved to be only the first of many young children I’ve seen sprawled in hospital beds, horribly bloated and discolored, hooked up to kidney dialysis and life support machines, surrounded by doctors frustrated by a disease for which there is no known cure. Many of these kids died. Brianne barely survived, and she will suffer after-effects from her E. coli poisoning for the rest of her life. I hope that suffering is eased somewhat by the $15.6 million settlement eventually paid by the company. Jack in the Box, co-defendants and insurers paid out over $125 million in compensation to victims. The costs to the businesses involved were at least twice that.

At the time, E. coli O157:H7 was viewed as a pathogen carried only in ground beef—and especially beef crammed into industrial feedlots. There were outbreaks involving hamburger from virtually every fast food chain in America, ground beef from supermarkets, big box stores and public school lunches. People were getting sick around the country, and it was all blamed on meat. Since then, I’ve made a career of representing people poisoned by E. coli, Salmonella and a half-dozen other pathogens potentially carried in virtually every food, processed or unprocessed, fresh or packaged, industrial or homegrown. Here are just a few examples:

Shortly after the Jack in the Box case, we represented most of the seriously affected victims of an outbreak of E. coli traced to Odwalla apple juice.(3) Odwalla is a San Francisco-based processor that marketed “fresh” juice with no preservatives. At least 70 people fell ill, and a 16-month- old Colorado girl died, from drinking unpasteurized juice that is believed to have become contaminated by apples that fell off trees and into cow manure before being harvested. The case had a nationwide impact, demonstrating that food- borne illness can be contracted from fresh produce as well as meats. After an ugly legal fight, the company eventually paid a multi-million-dollar settlement to the victims and their families—and Odwalla began pasteurizing its juices using a flash pasteurization treatment.

Vegetables came next. In 2002, more than 50 high school cheerleaders and dancers contracted E. coli from prepackaged lettuce served at a dance camp in Washington.4 We represented several victims, including a Spokane teenager who had to endure dialysis treatments because her kidneys were severely damaged by the E. coli. The U.S. Food and Drug Administration (FDA) was sufficiently alarmed to issue a rare warning that consumers should throw out prepackaged bags of Romaine lettuce. The following year, at least 660 people were sickened, and four died, from hepatitis A contracted from Mexican green onions served at a Chi-Chi’s chain Mexican restaurant near Pittsburgh, Pennsylvania. The FDA attributed the outbreak to poor sanitation, leading to the largest single- source epidemic of hepatitis A in U.S. history.(5 ) We represented many of the approximately 300 victims who sought compensation from Chi-Chi’s and four companies that supplied the green onions. One gentleman who required a liver transplant collected nearly $6.5 million. Total compensation to victims was nearly $50 million and Chi-Chi’s never exited bankruptcy.

In 2006, a nationwide E. coli epidemic was attributed to prepackaged, fresh-cut spinach packed for Dole Foods by Natural Selection Foods LLC, a California company that specializes in processing specialty lettuces, primarily spinach and spring mix. The Centers for Disease Control and Prevention (CDC) and FDA confirmed 204 illnesses in 26 states—including a frightening 31 with HUS—104 hospitalizations, and three deaths associated with this outbreak. Victims of the E. coli outbreak were identified in 26 states. E. coli was isolated on cattle ranches adjacent to the spinach fields.(6) We represented 93 of the victims.

It goes on and on. We have handled cases of foodborne illness traced to packaged almonds, homemade apple cider, alfalfa sprouts, fruit salad, packaged breakfast cereal, sushi, orange juice, tomatoes, cantaloupe, gelatin desserts, and most recently, peanut butter. The microorganisms involved in these outbreaks range from Listeria monocytogenes, to E. coli O157:H7, to numerous strains of Salmonella, and include microbial toxins and viruses such as Clostridium botulinum, Cryptosporidium, Vibrio, hepatitis A, and Norwalk virus, to name a few. We have represented thousands of clients, sued most of the nation’s large restaurant chains and won a total of $600 million in judgments and settlements.

Managing Risk is Part of Managing the Business

So what’s happening out there? Is there an epidemic of E. coli and Salmonella and other foodborne illness? Or is it just a bunch of guys like me, chasing ambulances and making life miserable for hardworking CEOs? We know, after all, that people have been getting sick from eating tainted meat, fruits, vegetables and dairy products since the beginning of human history; and it may well be true that, thanks to advances such as pasteurization and flash freezing, that food is actually safer than it was 50 years ago. So why is this happening now?

First, it may be true that industrial food production fosters an environment friendlier to these bugs. Enormous feedlots, centralized processing plants, long-distance shipping, and even air conditioning systems may create new opportunities for pathogens to spread. And in any case, big business makes the system less tolerant of error. If a small town processing plant has an outbreak, a few people might be infected—perhaps too few to detect. But today, with extended and increasingly efficient supply chains, a mistake in a peanut butter plant in Georgia or meat packing plant in Colorado can quickly sicken thousands of people around the country or even on a global scale.

Second, recent technological advances, especially DNA analysis, provide new tools for detecting, tracking and identifying pathogens such as E. coli O157:H7. It’s only very recently that we can establish a direct and virtually certain link between one or more sick people and a specific food source. My job would be far more difficult without DNA analysis. The bottom line is that with technology comes the great likelihood that a company that produces tainted food will get caught.

And, perhaps contemporary society is less tolerant of risk, as well. People these days expect to be healthy. When they get sick, they want to know why. And if they know why, they want to hold somebody accountable. You can argue with that phenomenon, but it is a fact of life.

So, what can you do about it? How can you manage your own business and produce a healthy and profitable product without making people sick? Given these new realities, how can we manage risk in a free society? There are three broad options.

First, we can do what most Western societies have do for most of their history, and what much of the world still does today,which is to rely on the open market. In part, it is up to the individual consumer. We can choose to trust our farmers and food processors, and the marketplace will take care of everything else. If they make an error and some of our kids get sick, that is too bad. The marketplace imposes sanctions; if people are afraid of getting sick, they’ll stop buying the product. Case closed.

We know the problem with that. Consider the case of those nice people in California who produced unpasteurized apple juice, poisoning hundreds of kids. Most farmers and processors will be conscientious. But a few bad apples will get lazy, or cocky, and make a fatal mistake. Consumers will become wary not of just one bad apple, but of the entire apple industry. Everybody in the affected food category pays the consequences of one outfit’s error.

The second option is Big Brother: regulate. We enact laws, impose penalties and hire the inspectors necessary to enforce them. But my guess is that this solution doesn’t appeal to anybody in any business. To make it work, we would need trained inspectors on every farm, in every processing plant, in every restaurant, at every hot dog stand. It’s expensive, and potentially too intrusive. And there’s another problem: Regulatory systems may work for a while but success tends to be followed by breakdowns. Inspectors get lazy, or corrupt, and stop doing their jobs. Or the political system intervenes; government budgets come under strain and politicians look at the system and conclude that nobody is getting sick, so clearly we don’t need so many inspectors. They cut budgets, the regulatory system gets stretched too thin, some E. coli bacteria slip through the cracks, and suddenly we have another tragic outbreak.

The third option is the legal system. If people get sick, we allow them, even encourage them, to go to court and sue for compensation. Food producers go about their business, and if they do everything right, they’re fine. But if somebody gets sick then somebody like me will probably be waiting at his or her doorstep. And I will do my best to make it a very costly mistake. But civil law, of course, has its own costs. Even if you run a flawless business and never poison anybody, you need to carry enough insurance to spread the risks and costs across your industry.

In the U.S., we’ve seen the evolution of a political system that is a mix of each of these elements. We have a market system that theoretically rewards farmers and producers who don’t take risks—or, at least, whose mistakes are not detected and traced back to the source. We have a regulatory system of food safety laws and enforcement, though that system is, by almost any account, woefully inadequate in funding, staffing and efficiency to enforce the laws presently in force, let alone any new and tougher body of law. And we have civil laws that allow people to seek compensation for their injuries.

Whatever strategies we employ to prevent foodborne illness, the analysis should not be purely political or legal. We could criminalize food poisoning (see what China does), employ thousands of inspectors and impose stiffer penalties for people who produce tainted food. But ultimately, this is also a fundamental question of morality. As individuals and as businesses, do we subscribe to the Law of the Jungle? Or to the Golden Rule? If food producers, and their CEOs, put themselves in the position of food consumers, perhaps it would be easier for them to understand why consumers need to be able to trust their food supply. If CEOs could see what I’ve seen—two- and three-year-old children hooked up to kidney dialysis machines and life support, or in their tiny coffins—it might change some attitudes about the importance of food safety.

If that were to happen, the food industry would profit, consumers would be safer, and lawyers like me would have to look for another way to make a living.

The CEO’s Checklist

I often speak to food manufacturers, foodservice and retailers about why CEOs and senior management (even outside of the traditional food safety or quality assurance department functions) must be dedicated to food safety, as I’ve related above. But I also have a few recommendations for translating the “why” into a practical “how.” The fact is, paying attention to headlines isn’t nearly as important as paying attention to your food safety management professionals on staff and those with whom you contract for their food safety systems expertise. CEOs are in the business of managing the business to make a profit—whether you are a multinational food manufacturer or a one-shop restaurant owner—and are not necessarily versed in the lingua franca of science-based solutions that microbiologists, chemists or food engineers propose. But investments in food safety systems, technologies, testing and tools are just that—economic investments of either money, staff or time that must be justified at the bottom line or to the company’s shareholders. This is why my first recommendation to CEOs is to ensure that the company is placing qualified people in charge of food safety—and the second is to listen to them.

1. Put qualified people in charge of food safety. Invest in hiring scientists and experienced quality assurance professionals to manage the food safety programs. These individuals can often be trained in management techniques that will help them articulate to CEOs and senior level management the basis for requests to implement or improve food safety programs that involve technical concepts.

Providing and supporting general and overall training programs to food safety leaders in your organization is also important. You want to keep your qualified staff qualified. Continuous training and education of food safety department heads, managers and staff practical way that CEOs can ensure they are getting the most up-to-date information and recommendations from which to make critical—and proactive—food safety decisions.

This may mean investing in fee-based training or professional certification or accreditation seminars in planning and implementing Hazard Analysis and Critical Control Points (HACCP) programs, specialized testing laboratory workshops for technicians and supervisors, or even train-the-trainer type courses in auditing methods or safe food handling. For smaller companies, off-the-shelf and customized software programs and video and audio training can be a cost-effective way to achieve professional development of your food safety staff.

Also, encourage food safety professionals in your organization to get involved with recognized industry and scientific organizations, and to attend these organizations’ trade conferences, participate in committees and network with other food safety colleagues and leaders in the field—and fund it. Food safety is not a competitive issue and supporting your staff in these types of collegial, educational endeavors will help them deepen their knowledge of emerging trends, issues and solutions, which in turn improves corporate knowledge and decision-making effectiveness.

2. Listen to the qualified food safety professionals you’ve hired. Understanding what your in-house experts or outside contract professionals are recommending is key to investing in the right food safety systems and technologies—and to helping you justify associated costs to relevant stakeholders on the business side. Pay attention to what the experts advise are the existing or potential risks to your operation. Not all microbes, viruses or chemical contaminants are equal when it comes to the likelihood of adulterating particular foods or beverages. But, if you are manufacturing ready-to-eat luncheon meat or deli salads, it is important to know that these have been ranked as products with a very high risk for Listeria monocytogenes contamination if appropriate preventive strategies and systems are not in place. The operation may have other bugs to worry about but identifying the “baddest” bug helps senior managers understand why recommended technologies, equipment or systems investments should be implemented faster than others. Similarly, restaurant and other foodservice establishments where food is handled know that risks associated with poor personnel hygiene practices, among others, can result in the spread of hepatitis A, noroviruses and other illnesses. Knowing this makes it easier to make the investment decision to improve employee training or provide more handwashing stations. Your food safety professionals should be able to identify and rank the risk factors associated with your particular processing or food handling/distribution operations and provide information on the management strategies or technological solutions that will mitigate or eliminate those risks.

It is great to have good advice that you, as a critical decision maker, can trust but you must be able to translate that into action. When the head of food safety recommends a capital investment in new equipment that is of sanitary design, be prepared to see past the new line item it represents. Rather, focus on listening to the why’s, what’s and how’s of the presented material to better understand how your company can get a return on investment for the proposed expenditure.

3. Use contracts with your vendors to protect your customers and indemnify your company of liability if something goes wrong. Putting pressure on your suppliers to make sure they take into account food safety is a good thing. Your product is only as safe as its component parts. Requiring suppliers to be bound by your specifications makes the risks lower that and error will occur. And, if a supplier’s product is contaminated, shouldn’t it pay for its error and not you?

4. Understand why information management (IT) is important to your company, especially as it relates to the food safety mission. In today’s high-tech climate and global economy, it is more important than ever to develop and implement IT systems that increase the food company’s effectiveness in making collected food safety data meaningful. Without this “usability” factor, critical data on traceability, sanitation and food safety audit findings, testing results, and HACCP, allergen control or other food safety management and control systems are essentially impotent. Streamlined, inter-departmental management and reporting of food safety data helps senior management see the big picture and navigate a course that takes into account all areas that involve the food safety imperative.

5. Stay current with regulatory and code compliance for every jurisdiction in which your company operates. Certainly, food company CEOs and senior level managers who are educated about the applicable food safety laws and regulations that govern the production, distribution or handling of foods and beverages are better prepared to respond to a crisis or recall event. But perhaps more importantly, those who are more knowledgeable about these laws and rules are able to make food safety improvement decisions that foster proactive compliance.

From the Top

Ultimately, dedication to food safety must go beyond the company’s HACCP program—in terms of compliance, implementation, testing and auditing. This commitment starts at the top of the organization with the CEO, president and senior management team. Managing the business in a way that pays more than lip service to food safety will produce high-quality, profitable products that don’t make people sick, and is essential to the continued health of your bottom line and the health of your consumers.

References

1. CDC. Epidemiologic Notes and Reports Isolation of E. coli O157:H7 from Sporadic Cases of Hemorrhagic Colitis—United States. MMWR Nov. 5, 1982. 31(43); 580,585. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001184.htm.

2. CDC. Update: Multistate Outbreak of E. coli O157:H7 Infections from Hamburgers—Western United States, 1992-1993. MMWR April 16, 1993. 42(14);258-263. http://www.cdc.gov/mmwr/preview/mmwrhtml/00020219.htm.

3. CDC. Outbreak of E. coli O157:H7 Infections Associated with Drinking Unpasteurized Commercial Apple Juice—British Columbia, California, Colorado, and Washington, October 1996. MMWR Nov. 8, 1996. 45(44), 975. http://www.cdc.gov/mmwr/preview/mmwrhtml/00044358.htm.

4. California Department of Health Services. E. coli O157:H7 Illnesses in Washington— July, 2002. Final Report. Oct. 29, 2002. http://www.dhs.ca.gov/ps/fdb/local/PDF/02_07reportweb.pdf.

5. CDC. Hepatitis A Outbreak Associated with Green Onions at a Restaurant—Monaca, Pennsylvania, 2003. MMWR Nov. 21, 2003. 52 Dispatch;1-3. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm52d1121a1.htm.

6. California Department of Health Services. CDHS Investigation of an E. coli O157 H7 Outbreak Associated with Consumption of Dole Brand Prepackaged Baby Spinach Manufactured by Natural Selection Foods: Sept. 13, 2006 – March 21, 2007. Redacted. http://www.dhs.ca.gov/ps/fdb/local/PDF/2006%20Spinach%20Report%20Final%20redacted.pdf.

Reprinted from Food Safety Magazine – October/November 2007

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do you require records from your suppliers?

do you require records from your suppliers?.

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Blog Talk Radio with Andy Moreno One Step Forward One Step Back Food Safety and Traceability

I did an AME BlogTalk Radio show recently. One Step Forward One Step Back Food Safety and Traceability.
http://www.blogtalkradio.com/ame-foodtestingshow/2013/03/06/one-forward-one-back-food-safety-traceabilitypamela-s

Why does food safety require traceability of products?
What are the minimum requirements of traceability?
What does One Step Forward mean?
What does One Step Back mean?
What are the best practices for food managers to engage to assure traceability?

Pamela Sweeten
P. Sweeten Consulting
209-606-1418
pamela@trackmycrop.com
http://www.trackmycrop.com

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The Food and Drug Administration is asking for feedback on a food traceability report to help craft future rules.

The Food and Drug Administration is asking for feedback on a food traceability report released on Monday. The 300-page report, which looks at two pilot projects that were mandated by the Food Safety Modernization Act, along with the comments the agency receives, will inform a future rule on recordkeeping requirements that could vastly improve traceability in the food chain.

The report, which involved numerous stakeholders, was crafted by the Institute of Food Technologists (IFT) over the past couple years. The organization conducted two pilot projects — one on tomatoes and one on chicken, peanut butter and spices used in processed food — designed to look at how food can be rapidly tracked and traced, what types of data are needed and how the data can be made available to FDA.

On top of being chock-full of information on food tracing, the IFT report also makes several recommendations to FDA. IFT suggests, among other things, that the agency establish a uniform set of recordkeeping requirements for all all FDA-regulated foods, with no exemptions based on risk, and that each member of the food supply be required to develop a product tracing plan. The document also calls on FDA to be more clear in communicating what it needs from industry to conduct food tracing investigations and says FDA should considering adopting a technology platform that would allow “efficient aggregation and analysis” of data submitted to FDA on request.

“We’re looking for input on where we should go with this information,” said Sherri McGarry, Senior Adviser to the CORE Network in the Office of Foods at FDA. McGarry noted that under FSMA, FDA is limited to requiring recordkeeping for high-risk foods, not all FDA-regulated foods. She said FDA would consider eventually issuing a guidance aimed at improving traceability for other low-risk foods not covered by the future rule.

McGarry said that the agency has high hopes for improving traceability in the coming years. With improved technology and recordkeeping and data requirements, the FDA could one day visualize food supply chains and actually see how they interconnect and overlap during a foodborne illness outbreak, enabling investigators to hone in on the problem quickly.

“[The report] is really encouraging,” said McGarry. “It gives us more specifics on what can be improved, both in the industry and at FDA.”

FDA requested the information to help the agency form its own recommendations on improving traceability, which it will ultimately offer in a Report to Congress, as mandated by FSMA.

“The produce industry has been looking forward to these traceability recommendations to make sure that we can move confidently with the traceability best practices that we have collectively developed in the [Produce Traceability Initiative],” said Mike Agostini, Senior Director of Produce at Wal-Mart Stores and co-chair of the PTI Leadership Council, in a statement on Monday. “Our industry community is excited to have the opportunity to delve into the details of the report and provide feedback to FDA.”

FDA invited those interested in submitting comments to do so over the next 30 days. To submit comments electronically, go to http://www.regulations.gov and enter docket number FDA-2012-N-1153.

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2 Years In The Making – FDA Releases Two Long-Awaited Food Safety Modernization Act Rules

After a year-long delay, two sweeping new food safety rules that will for the first time mandate produce safety standards and preventive controls nationwide will be released today and published to the Federal Register on Monday, according to the U.S. Food and Drug Administration.

“It’s a big deal that these two are coming out because it’s the central framework for prevention,” said Michael Taylor, FDA’s Deputy Comissioner for Foods and Veterinary Medicine, in an interview with Food Safety News. “We’re eager to get to the next phase of the process.”

The two rules were mandated by the Food Safety Modernization Act (FSMA) — a law that aims to shift the U.S. food safety system from being primarily reactive to focusing on prevention — which President Obama signed into law, with broad bipartisan support, exactly two years ago.

Since the law was enacted, the FDA has failed to keep up with the multiple deadlines set by Congress, in large part because the measures proposed by the agency were under review at the White House Office of Management and Budget’s Office of International and Regulatory Affairs for more than a year — a delay many stakeholders blamed on election politics.

It is still not clear exactly why the Obama administration’s review took so long (OMB officials have long maintained the rules are just complex and take time). According to Taylor, the OMB’s cost-benefit analysis, which will soon be posted online, found that the the economic benefits from the two new rules are much greater than the expected costs to the food industry.

“There are significant benefits that well exceed the estimated costs,” said Taylor, adding that preventing outbreaks and the health care costs associated with them is actually one small part of the expected economic benefit. “There’s a great benefit in reducing the disruption to the markets, the loss of sales, and the loss of consumer confidence each time a major foodborne illness outbreak strikes.”

The agency has made full drafts of the proposed rules, which are lengthy, available online. The public will have 120 days to comment and then the rule will go through the normal rulemaking process, which could take several months.

It will likely take time for stakeholders to review the proposed rules, as the agency has not yet released an overview of what exactly would be required under the proposal, but the early reactions were unanimously positive.

“We applaud the Administration’s release of these important proposals,” said Sandra Eskin, director of the food safety campaign at the Pew Charitable Trusts. “This is a significant step forward in reducing preventable foodborne illnesses and restoring consumer confidence in the food supply.”

The Grocery Manufacturers Association said that industry and government need to work together “to provide Americans and consumers around the world with the safest possible products” and called FSMA implementation a “role mode” for this type of cooperation.

“We are pleased that implementation of FSMA is moving forward and look forward to working with the FDA by continuing to share our food safety expertise and best practices and by evaluating and commenting on the proposed rules,” said Pamela Bailey, the president and CEO of GMA.

Joe Levitt, a partner at Hogan Lovells, which represents food industry clients, called the two new rules “form the cornerstone of FSMA.”

“They get to the very heart of the new law’s paradigm shift from reaction to prevention,” said Levitt, who formerly served as Director of FDA’s Center for Food Safety and Applied Nutrition. “As with all FDA proposed rules, public comment is a key component of the process, and the food industry and other stakeholders will review these proposals thoroughly and submit comments to FDA on how to make the final rules as beneficial and cost-effective as possible.”

The agency plans to do extensive outreach to stakeholders to have a “real dialogue” and ensure all elements of the food industry understand the new requirements.

“This is the first time we’ve ever had enforceable standards on the farm. It’s the first time we’ve tried to apply preventive controls across all types of operations,” said Taylor. “What I think we’ll see, especially in the produce community, where standards are new is that we’re going to need to work with the community to explain what we’re proposing and to explain how the flexibilities work.”

“There are many, many examples of where we’ve built flexibility into the rules so the requirements are adaptable to the particular circumstances of a farm: what they’re growing, how they’re growing it, the way they use water, and so forth,” he added.

If produce growers, for instance, are already paying attention to food safety by implementing good agricultural practices (GAPs), and doing rigorous certifications, there may not be anything new or surprising about the produce rules, according to Taylor.

One of the key elements of the proposed rule for produce focuses on water. If a farm is applying water to the edible part of the crop, it will likely have to meet a microbial standard, or explain why such a standard isn’t relevant to that specific product.

There are three other key draft rules that remain under review at OMB, two that have been there for more than a year, on foreign supplier verification and preventive controls for the feed industry, and one on third party audit certification, which was only recently submitted to the administration.

Taylor said he expects the remaining rules will be released “shortly,” but declined to provide a specific timeline. “I know people are working hard on it.”

While releasing the rules is a big step toward implementing FSMA, many stakeholders remain concerned the agency won’t have the resources to enforce them.

“We’ve said from the beginning we’ll need additional resources to fully implement this,” said Taylor. The Congressional Budget Office estimates FDA would need about $1.5 billion in additional funds over five years to do so, but so far Congress has not provided anywhere near that level of funding.

This article has been updated.

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